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FDA 510(k) Application Details - K171822
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K171822
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
Biotest Medical Corporation
No. 3-2, Chien-kuo Rd., TEPZ Tantzu dist.
Taichung 42760 TW
Other 510(k) Applications for this Company
Contact
Fred Lee
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/19/2017
Decision Date
09/20/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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